Local Advanced or Metastatic NSCLCPhase 3NCT06380348
JMT101 in Combination With Osimertinib, Versus Cisplatin-pemetrexed in Participants With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) Characterized by Epithermal Growth Factor Receptor (EGFR) Exon 20ins Mutations
A Phase 3 study testing JMT101 Injection, Osimertinib tablet and Cisplatin injection in people with Local Advanced or Metastatic NSCLC, run by Shanghai JMT-Bio Inc..
Trial summary
This is a multicenter, randomized, open-label, parallel-controlled phase 3 study. This study aims to evaluate the efficacy and safety of JMT101 combined with Osimertinib compared with Cisplatin combined with pemetrexed in participants with local advanced or metastatic non-small-cell lung cancer harboured EGFR 20ins… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Local Advanced or Metastatic NSCLC
- What is being tested?
- JMT101 Injection, Osimertinib tablet and Cisplatin injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 398 participants
- Where
- No sites listed yet
- Study dates
- 26 Apr 2024to 26 Mar 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18-75 years old.
- Histologically or cytologically confirmed diagnosis of NSCLC, locally advanced (Stage IIIB and IIIC according to the 8th edition of the IASLC TNM staging criteria) or metastatic (Stage IV), not suitable for curative therapy. For central laboratory confirmation of EGFR exon 20 insertion mutation with tumour tissue/blood sample.
- At least 1 measurable lesion per RECIST Version 1.1
- Life expectancy ≥ 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
- Adequate organ and hematologic function
Who cannot join
- Prior treatment with any systemic anti-cancer therapy for locally advanced or metastatic NSCLC.
- Central nervous system metastasis with associated symptom and signs.
- Concurrent EGFR mutations: exon 19 deletion, L858R, T790M, G719X, S768I, or L861Q.
- History of interstitial lung disease, or infectious pneumonitis need heavy antibiotics therapy
- As judged by the investigator, unsuitable for attending the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Open-label, Parallel-controlled Phase 3 Study of Combination JMT101 and Osimertinib Compared With Cisplatin -Pemetrexed in Patients With EGFR Exon 20ins Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
This is a multicenter, randomized, open-label, parallel-controlled phase 3 study. This study aims to evaluate the efficacy and safety of JMT101 combined with Osimertinib compared with Cisplatin combined with pemetrexed in participants with local advanced or metastatic non-small-cell lung cancer harboured EGFR 20ins mutation without prior systemic therapy.
Primary objective of this study is to assess the efficacy of JMT101 combined with Osimertinib versus Cisplatin combined with pemetrexed using by （Independent Review Center）IRC-assessed Progression Free Survival (PFS) per RECIST 1.1 as primary endpoint. Approximately 398 participants are estimated to be randomized into the study. Participants enrolled will be randomized to JMT101 or Cisplatin chemotherapy in a 1:1 manner, stratified by baseline brain metastasis (with/without) and Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) (0 versus 1).
- Conditions
- Local Advanced or Metastatic NSCLC
- Being tested
- JMT101 Injection, Osimertinib tablet, Cisplatin injection, Pemetrexed injection
- Keywords
- Harboring EGFR 20ins mutation, Without prior systemic therapy
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JMT101 InjectionDrug
JMT101 Injection, 6 mg/kg intravenously, over 90 mins every 14 days
Osimertinib tabletDrug
Osimertinib 160mg once po everyday
Cisplatin injectionDrug
Cisplatin 75mg/m^2, IV infusion, on day-1 at every cycle of 21days, 4 cycles at most.
Pemetrexed injectionDrug
Pemetrexed 500mg/m^2, IV infusion, on day-1 at every cycle of 21 days.
| Study group | Role | What they receive |
|---|---|---|
| JMT101 combined with Osimertinib | Experimental | Not described Receives: Drug: JMT101 Injection; Drug: Osimertinib tablet |
| Cisplatin combined with pemetrexed | Active comparator | Participants randomized into chemotherapy arm can receive up to 4 cycles of pemetrexed + cisplatin (pemetrexed 500 mg/m^2 + cisplatin 75mg/m^2, IV infusion, every 3 weeks) as the initial treatment. Participants whose disease has not progressed after 4 cycles of first-line platinum-based doublet chemotherapy may receive pemetrexed maintenance monotherapy until a treatment discontinuation criterion is met. Receives: Drug: Cisplatin injection; Drug: Pemetrexed injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS) as assessed by Independent Review Center (IRC) per RECIST 1.1
Measured: Up to approximately 35 months after the first participant is randomized
Secondary outcomes (6)
Overall Survival (OS)
Measured: Up to approximately 35 months after the first participant is randomized
Overall Response Rate (ORR) by IRC per RECIST 1.1
Measured: Up to approximately 35 months after the first participant is randomized
Duration of Response (DoR) by IRC per RECIST 1.1
Measured: Up to approximately 35 months after the first participant is randomized
PFS by investigator per RECIST 1.1
Measured: Up to approximately 35 months after the first participant is randomized
ORR by investigator per RECIST 1.1
Measured: Up to approximately 35 months after the first participant is randomized
DoR by investigator per RECIST 1.1
Measured: Up to approximately 35 months after the first participant is randomized
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start26 Apr 2024 (estimated)
- Primary completion26 Mar 2027 (estimated)
- Study completion26 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Local Advanced or Metastatic NSCLCStudies of the same condition, open and under way.
- More trials run by Shanghai JMT-Bio Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 398 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai JMT-Bio Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Li Zhang, M.D., Principal investigator, Cancer Prevention and Treatment Center of Sun Yat sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06380348
- Sponsor's protocol ID
- JMT101-012
- Status last verified
- Apr 2024
- First submitted
- 9 Apr 2024
- Last updated
- 23 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-label, Parallel-controlled Phase 3 Study of Combination JMT101 and Osimertinib Compared With Cisplatin -Pemetrexed in Patients With EGFR Exon 20ins Mutated Locally Advanced or Metastatic Non-Small Cell Lung Cancer
- ClinicalTrials.gov ID
- NCT06380348
- Acronym / sponsor ID
- JMT101-012
- Conditions
- Local Advanced or Metastatic NSCLC
- Keywords
- Harboring EGFR 20ins mutation, Without prior systemic therapy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 398 participants (estimated)
- Lead sponsor
- Shanghai JMT-Bio Inc.Industry (pharma, biotech, devices)
- Study start
- 26 Apr 2024 (estimated)
- Primary completion
- 26 Mar 2027 (estimated)
- Study completion
- 26 Mar 2028 (estimated)
- First posted
- 23 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a multicenter, randomized, open-label, parallel-controlled phase 3 study. This study aims to evaluate the efficacy and safety of JMT101 combined with Osimertinib compared with Cisplatin combined with pemetrexed in participants with local advanced or metastatic non-small-cell lung cancer harboured EGFR 20ins mutation without prior systemic therapy.
Primary objective of this study is to assess the efficacy of JMT101 combined with Osimertinib versus Cisplatin combined with pemetrexed using by （Independent Review Center）IRC-assessed Progression Free Survival (PFS) per RECIST 1.1 as primary endpoint. Approximately 398 participants are estimated to be randomized into the study. Participants enrolled will be randomized to JMT101 or Cisplatin chemotherapy in a 1:1 manner, stratified by baseline brain metastasis (with/without) and Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) (0 versus 1).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| JMT101 combined with Osimertinib | Experimental | Drug: JMT101 Injection, Drug: Osimertinib tablet |
| Cisplatin combined with pemetrexed | Active comparator | Drug: Cisplatin injection, Drug: Pemetrexed injectionParticipants randomized into chemotherapy arm can receive up to 4 cycles of pemetrexed + cisplatin (pemetrexed 500 mg/m^2 + cisplatin 75mg/m^2, IV infusion, every 3 weeks) as the initial treatment. Participants whose disease has not progressed after 4 cycles of first-line platinum-based doublet chemotherapy may receive pemetrexed maintenance monotherapy until a treatment discontinuation criterion is met. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 18-75 years old.
- Histologically or cytologically confirmed diagnosis of NSCLC, locally advanced (Stage IIIB and IIIC according to the 8th edition of the IASLC TNM staging criteria) or metastatic (Stage IV), not suitable for curative therapy. For central laboratory confirmation of EGFR exon 20 insertion mutation with tumour tissue/blood sample.
- At least 1 measurable lesion per RECIST Version 1.1
- Life expectancy ≥ 12 weeks
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1
Key exclusion criteria (5 listed)
- Prior treatment with any systemic anti-cancer therapy for locally advanced or metastatic NSCLC.
- Central nervous system metastasis with associated symptom and signs.
- Concurrent EGFR mutations: exon 19 deletion, L858R, T790M, G719X, S768I, or L861Q.
- History of interstitial lung disease, or infectious pneumonitis need heavy antibiotics therapy
- As judged by the investigator, unsuitable for attending the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JMT101 InjectionJMT101 Injection, 6 mg/kg intravenously, over 90 mins every 14 days | Drug | JMT101 combined with Osimertinib |
| Osimertinib tabletOsimertinib 160mg once po everyday | Drug | JMT101 combined with Osimertinib |
| Cisplatin injectionCisplatin 75mg/m^2, IV infusion, on day-1 at every cycle of 21days, 4 cycles at most. | Drug | Cisplatin combined with pemetrexed |
| Pemetrexed injectionPemetrexed 500mg/m^2, IV infusion, on day-1 at every cycle of 21 days. | Drug | Cisplatin combined with pemetrexed |
Primary outcome
Progression Free Survival (PFS) as assessed by Independent Review Center (IRC) per RECIST 1.1
Time frame: Up to approximately 35 months after the first participant is randomized
6 secondary outcomes
Overall Survival (OS)
Time frame: Up to approximately 35 months after the first participant is randomized
Overall Response Rate (ORR) by IRC per RECIST 1.1
Time frame: Up to approximately 35 months after the first participant is randomized
Duration of Response (DoR) by IRC per RECIST 1.1
Time frame: Up to approximately 35 months after the first participant is randomized
PFS by investigator per RECIST 1.1
Time frame: Up to approximately 35 months after the first participant is randomized
ORR by investigator per RECIST 1.1
Time frame: Up to approximately 35 months after the first participant is randomized
DoR by investigator per RECIST 1.1
Time frame: Up to approximately 35 months after the first participant is randomized
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Li Zhang, M.D. principal investigator
Cancer Prevention and Treatment Center of Sun Yat sen University
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing JMT101 Injection, Osimertinib tablet and Cisplatin injection in people with Local Advanced or Metastatic NSCLC, run by Shanghai JMT-Bio Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Information Group officer (86-0311-69085587, ctr-contact@mail.ecspc.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) as assessed by Independent Review Center (IRC) per RECIST 1.1 (time frame: Up to approximately 35 months after the first participant is randomized). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2024.